2024-513814-37-00招募中4 期
Efficiency of everolimus for the treatment of kidney transplanted patients presenting a missing self-induced NK-mediated rejection (STARR)
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Relative variation in Glomerular Filtration Rate (GFR) estimated by the CKD-EPI method between D-15 and M6 after starting everolimus.
研究概览
简要总结
To evaluate the effectiveness of everolimus in preventing deterioration of graft function at 6 months in adult kidney transplant patients with NK-mediated rejection
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized
- 主要目的
- Everolimus
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Major renal transplant patient
- •Patient who had a renal graft biopsy as part of the usual follow-up finding microvascular inflammatory lesions (glomerulitis + peritubular capillaritis ≥ 2) associated with moderate chronic lesions (cg < 3 and cv < 3) according to the Banff classification 2013
- •Having a predictable “missing self”: patient having a mismatch between the HLA class I ligands of inhibitory KIRs present in the recipient and the ligands present in the recipient
- •Patient receiving at least dual immunosuppressive therapy including: an anticalcineurin (tacrolimus or cyclosporine), an antimetabolite (mycophenolic acid (CELLCEPT or MYFORTIC) or azathioprine (IMUREL)).
- •Taking effective contraception for up to 8 weeks after the end of treatment with everolimus (CERTICAN)
- •Patient affiliated to a social insurance regimen
- •An absence of anti-endothelial cell antibodies in their serum tested for by an endothelial cross match
- •At least 1 confirmed missing self: the recipient has at least one functional KIR inhibitor present genotypically whose HLA class I ligand is not present in the donor
排除标准
- •Patients at high immunological risk: presence of preformed specific anti-HLA antibodies or hyperimmunized patients (incompatible graft rate > 85%) on the day of the transplant.
- •Subject participating in another research including an exclusion period still in progress at pre-inclusion
- •Pregnant, breastfeeding women, minors, adults under guardianship or curatorship
- •Proteinuria > 1 g/day (or 100 mg/mmol creatininuria)
- •History of poor tolerance of everolimus
- •Hypersensitivity to everolimus, sirolimus or one of its excipients as mentioned in the SPC of everolimus paragraph 4.3 and 6.
- •Galactose intolerance, total lactase deficiency or glucose-galactose malabsorption syndrome
- •Surgery planned for the next 6 months
- •Severe chronic lesions (cg > 2 or cv > 2) according to the Banff 2013 classification on the classic histological examination of a graft biopsy
- •Presence of donor-specific anti-HLA antibodies in their serum on the day of the biopsy searched by Luminex
- •Positive endothelial cross match with serum from the day of the biopsy
结局指标
主要结局
Relative variation in Glomerular Filtration Rate (GFR) estimated by the CKD-EPI method between D-15 and M6 after starting everolimus.
Relative variation in Glomerular Filtration Rate (GFR) estimated by the CKD-EPI method between D-15 and M6 after starting everolimus.
次要结局
- Histological: variation in the microvascular inflammation score (g+cpt) and chronic glomerular (cg) and vascular (cv) lesions determined according to the Banff 2013 classification between D-15 and M6
- Biological: variation in the degree of in vitro activability of NK between D0 and M6
- Clinical: relative variation in the proteinuria/creatininuria ratio between D-15 and M6
研究者
Dr Koenig
Scientific
Hospices Civils De Lyon
研究点 (1)
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